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FDA 510(k)

AMISCO U-100 INSULIN SYRINGE

K-Number: K882114 · 1988-08-23

ApplicantAmerican Intl. Medical Supply Co.
Decision Date1988-08-23
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMISCO U-100 INSULIN SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is American Intl. Medical Supply Co.. It received FDA 510(k) clearance on 1988-08-23 under 510(k) number K882114. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMISCO U-100 INSULIN SYRINGE?

AMISCO U-100 INSULIN SYRINGE is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is American Intl. Medical Supply Co.. The 510(k) number is K882114.

When did AMISCO U-100 INSULIN SYRINGE receive FDA 510(k) clearance?

AMISCO U-100 INSULIN SYRINGE received FDA 510(k) clearance on 1988-08-23, under 510(k) number K882114.

Who is the listed applicant for AMISCO U-100 INSULIN SYRINGE?

The FDA 510(k) record lists American Intl. Medical Supply Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMISCO U-100 INSULIN SYRINGE?

The FDA product code for AMISCO U-100 INSULIN SYRINGE is FMF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing American Intl. Medical Supply Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K832544SYSTENET

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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